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3 In 1 Hot Or Cold Gel Pack
EUDAMEDClass I (EU MDR)
Ref /Model AGFX43Model C502B0
Identity
- Trade Name
- 3 IN 1 HOT OR COLD GEL PACK EUDAMED
- Device Name
- 3 IN 1 HOT OR COLD GEL PACK EUDAMEDReusable Hot/cold packs EUDAMED
- Model / Reference
- AGFX43 EUDAMED/ EUDAMEDC502B0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973589091780 EUDAMED
- Basic UDI-DI
- B-06973589091780 EUDAMED697358909HP100MD EUDAMED
- Direct Marketing DI
- 06973589091780 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Hot/cold therapy pack, reusable
3 In 1 Hot Or Cold Gel Pack by Wuhan Pakcare Bio‐technology Co., Ltd. — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06973589091780 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06973589091780 | Class I | Active |
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Manufacturer
- Manufacturer
- Wuhan Pakcare Bio‐technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000008960
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (2)
- EUDAMED 16dcf1bb-8f3e-4c5f-8628-9e60f93bf839 61 fields · synced Jul 8, 2026
- EUDAMED 1d1800bd-579e-434b-8e8e-cfefed7d26cd 61 fields · synced May 19, 2026